Research Support - Laboratory/Non-Laboratory, Staff/Administrative
Employment Type: Permanent Staff (SHRA)
Vacancy ID: P011786
Salary Range: $40,944 - $47,768
The Regulatory Documents Specialist will work within the regulatory department of the Institute for Global Health and Infectious Diseases on clinical research and epidemiological studies. The primary purpose of this position will be to maintain and organize regulatory documents, study files and training records, communicate with study staff, IRB, sponsors, study partners, arrange meetings between all parties and take minutes, arrange monitoring visits and assist monitors, assist and create submissions for IRB, perform quality control and quality assurance of consent forms, assist in creation of SOPs and work instructions, create reports of study information, perform other administrative tasks as assigned by supervisor.
Education and Experience:
Bachelor’s degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.
The applicant should be knowledgeable about clinical research, IRBs, and regulatory affairs. Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
Applicant should be able to work in a fast-paced environment and to alternate between studies and various tasks as needed.
Applicant should be detail-oriented and conscientious.
Should also be comfortable communicating with study staff, investigators, IRB, study sponsors, domestic and international study partners, audit staff, including FDA.
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.
Carolina rates among the nation’s great institutions of higher education, set on an historic and beautiful campus that celebrates all four seasons. Carolina’s students, faculty and staff come here from around the world, bringing varied cultural, racial and ethnic heritages that help make UNC-Chapel Hill a thriving intellectual center. We’re repeatedly ranked the nation’s best value in higher education for students seeking to earn a college degree – the University has garnered the top spot each time since the ranking’s launch in 1998.Whether you’ve just started your career, are new to academia or are a seasoned professional with assorted campus experiences to draw on, we hope you will find a great place at Carolina.